# W. L. Gore and Associates, Inc.

- Location (FDA's records): Flagstaff, AZ
- FDA decisions: 4 (2018–2022): 3 510(k) clearances and 1 original PMA approval
- Product codes: MJN (1), DQY (1), OXF (1), MIH (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 2 (https://510kreport.com/company/w-l-gore-associates)
- Qxmedical, LLC: 1 (https://510kreport.com/company/qxmedical)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Recent decisions
- K222919: GORE® ENFORM Biomaterial (Dec 19, 2022)
- P200030: Gore Excluder Conformable AAA Endoprosthesis (CEXC) (Dec 22, 2020)
- K180919: GORE Tri-Lumen Catheter (Oct 5, 2018)
- K172567: GORE Molding and Occlusion Balloon Catheter (Jan 31, 2018)

Source page: https://510kreport.com/company/w-l-gore-and-associates